A Victim of Their Own Devices

Once again into the abyss. This time the issue is Guidant defibrillators. Solid reporting by Barry Meier of the New York Times raises some troubling and important matters. The first, of course, is what did Guidant know, when did they know it, and why did they delay reporting important adverse events to the FDA? The second, more troubling question, isn’t when the FDA knew — it’s why didn’t they act sooner. Or, to be more precise, how long did the report reside in a CDRH in-box before it was read and acted on. The first set of questions raise the specter of disquieting corporate shenanigans. But the issue of CDRH timeliness is, in the broader scope of the public health, more important, more troubling and, believe it or not, easier to address and remediate. The “front end” of CDRH functions well enough. The “back end,” the part that deals with post-market surveillance issues, not as well. The dedicated career staff at CDRH, under the respected leadership of Dan Schultz work hard — but they (like the rest of FDA) are under-funded and under-staffed. Let me be clear. There is no excuse for delay — but human beings can only do so much. Minus an increase in funding (which doesn’t seem to be in the cards any time soon) something else must be done, from a process perspective, to eradicate delays of potentially life-saving information. Even if Guidant had submitted its report on time, it’s likely the FDA would have taken the same amount of time to read it, digest the implications and issue the same public health advisory. The question isn’t confidentiality. That’s not even relevant. The issue is timeliness. And the answer is for the FDA to take a hard look at its existing processes and make them better. The New York Times, editorializing on its own report, recommends an interesting option — separate the wheat from the chaff. Ask device companies to provide a separate “hot sheet” that directs the FDA’s attention to the most crucial information — rather than burying it deep within the bowels of a more lengthy report. Drugs have risks and devices fail — that’s the world in which we live. And it’s all the more reason for device manufacturers to step up to the plate and be a more senior partner in protecting the public health. But corporate behavior is no excuse for an FDA process issue. A problem has been identified and a solution suggested. Now it’s time for the dedicated public servants at the FDA to solve it — and fast.